Celltrion’s Remdantry™ Set for Canada Launch on April 1, 2025
Celltrion, Inc., a global biopharmaceutical leader, has announced that its biosimilar Remdantry™ will be available in Canada starting April 1, 2025. Previously marketed under the name Inflectra®, Remdantry™ represents the same high-quality monoclonal antibody biosimilar to Remicade® (infliximab) that Canadian patients have relied on for years.
Regulatory Approval and Continuity of Treatment
Celltrion received Health Canada’s Notice of Compliance (NOC) for Remdantry™ on March 7, 2025. This approval ensures that the biosimilar maintains the same formulation, indications, dosages, and administration guidelines as its predecessor, Inflectra®.
Importantly, Remdantry™ will retain the same Drug Identification Number (DIN) as Inflectra®, meaning that the transition for healthcare providers and patients will be seamless. Physicians can continue prescribing the medication with confidence, knowing that the therapeutic properties remain unchanged.
Approved Indications and Clinical Use
Remdantry™ has been approved in Canada for the same indications as Inflectra®, making it a critical treatment option for patients with autoimmune diseases. These include:
- Rheumatoid arthritis (RA): To reduce signs and symptoms and improve physical function in adult patients when used in combination with methotrexate.
- Plaque psoriasis (PsO): For the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.
- Psoriatic arthritis (PsA): To reduce disease activity and improve joint function in adult patients.
- Ankylosing spondylitis (AS): To alleviate symptoms and improve mobility in patients with active AS.
- Crohn’s disease (CD) and fistulizing Crohn’s disease: For the treatment of moderate to severe Crohn’s disease in adults and pediatric patients (6 years and older), as well as fistulizing Crohn’s disease in adults.
- Ulcerative colitis (UC): For the treatment of moderate to severe ulcerative colitis in adult and pediatric patients (6 years and older) who have had an inadequate response to conventional therapy.
Commitment to Continuity and Supply Chain Stability
Celltrion Healthcare Canada is dedicated to ensuring uninterrupted access to Remdantry™ for Canadian patients.
“The availability of Remdantry™ in Canada is a step forward in Celltrion’s long-standing commitment to providing ongoing support to Canadian patients who have been using our products for years,” said Jungyong Shin, Managing Director at Celltrion Healthcare Canada.
The company reassured patients and healthcare providers that the transition to Remdantry™ will not impact treatment availability. The biosimilar will be sourced from Celltrion’s state-of-the-art manufacturing facilities in South Korea, ensuring a stable supply chain unaffected by external market factors such as tariffs or geopolitical disruptions.
CELLTRION CONNECT™: Comprehensive Patient Support Program
To further support patients and healthcare providers, it offers CELLTRION CONNECT™, a robust patient assistance program designed to ease access to treatment. The program includes:
- Reimbursement navigation: Guidance on insurance coverage and financial support options.
- Financial assistance: Programs to help eligible patients afford their medication.
- Infusion and nurse support services: Assistance with scheduling and coordinating infusion treatments.
- Educational resources: Information to help patients and caregivers understand their condition and treatment options.
Expanding Biosimilar Portfolio in Canada
Celltrion has been a leader in biosimilar development, and its presence in Canada continues to grow. In addition to Remdantry™, the company has received Health Canada approval for five other biosimilars:
- Remsima® SC: A subcutaneous formulation of infliximab.
- Yuflyma®: A biosimilar to Humira® (adalimumab), used to treat inflammatory diseases.
- Vegzelma™: A biosimilar to Avastin® (bevacizumab) for various cancers.
- SteQeyma®: A biosimilar to Stelara® (ustekinumab) used for psoriasis and inflammatory bowel disease.
- Omlyclo™: Another biosimilar advancing in immunology treatment.
Future Outlook
The launch of Remdantry™ in Canada underscores it’s dedication to expanding treatment options while maintaining affordability and accessibility for patients. As healthcare systems worldwide increasingly recognize the value of biosimilars in reducing costs without compromising efficacy, Celltrion continues to lead innovation in this field.
Patients and healthcare providers looking for more information about Remdantry™ and Cit’s biosimilar offerings can visit www.celltrionhealthcare.ca or contact it’s support team for assistance.
With this strategic expansion, Celltrion remains committed to improving global healthcare by providing high-quality, cost-effective biologic treatments to patients in need.
About Remdantry™, Celltrion’s infliximab, in Canada
Remdantry™ (infliximab for injection) is a biosimilar to the reference biologic drug Remicade®, that consists of a chimeric immunoglobulin G1 (IgG1) monoclonal antibody that binds with high affinity to the human tumour necrosis factor alpha (TNFα). Remdantry™ is indicated for the treatment of rheumatoid arthritis (RA), plaque psoriasis (PsO), psoriatic arthritis (PsA), ankylosing spondylitis (AS), Crohn’s disease (CD), fistulising Crohn’s disease and ulcerative colitis (UC).
About Celltrion, Inc.
Celltrion is a leading biopharmaceutical company that specialises in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people’s lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world’s first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, haematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us and stay updated with our latest news and events on our social media – LinkedIn, Instagram, X, and Facebook
About Celltrion Healthcare Canada Limited
Healthcare Canada is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with Health Canada regulations. Healthcare Canada currently has 6 biosimilars including: Remdantry™, Remsima® SC, Yuflyma®, Vegzelma™, SteQeyma® and Omlyclo™. For more information, please visit: https://www.celltrionhealthcare.ca
